Recruiting

Spartan Stem

Sponsor:

Signature Orthopaedics

Code:

NCT06172569

Conditions

Hip Replacement

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spartan Stem, World Acetabular Cup and World Liner

Study Details

Brief summary:

The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.

Conditions

Hip Replacement

Study ID

NCT06172569

Start date

Dec 8, 2023

Status verified date

Dec, 2023

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
  • patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient.
  • male and non-pregnant female patients aged 18-75
  • patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria:

  • patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
  • patient is a female of child-bearing age and not taking and not taking contraceptive pills
  • patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
  • patient has a known or suspected metal sensitivity
  • patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
  • patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
  • patient is severely overweight with a BMI>40.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Spartan Stem, World Acetabular Cup and World Liner

The Spartan Stem is a wedge-shaped fit and fill design stem with Titanium Plasma Spray(TPS) and Hydroxyapatite (HA) coating.

The World Acetabular cup is Porous coated and mated with cross-linked polyethylene World Liner

Primary outcome measure

  • Spartan Stem, World Acetabular Cup and World Liner Survival Rate [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Satish Shejale, MS Ortho

+61 02 9428 5181satish.shejale@signatureortho.com.au

Declan Brazil, PhD

+61 02 9428 5181declan@signatureortho.com.au

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Laura Stiegel

STIEGEL@ccf.org

More Information

Sponsor

Signature Orthopaedics

Last update posted

Dec 15, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Signature Orthopaedics on 2023-12-15.